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Open, Classified

Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.

FDA Recall Z-1561-2026 · Posted 2026-03-12

Recalling FirmAltruan GmbH
Recall StatusOpen, Classified
Product CodeGTY
Date Initiated2025-12-19
Product Quantity188 units

Reason for Recall

Product not cleared by the FDA.

Firm Action

The firm distributed a Recall Notice via email to consignees who purchased affected devices from Altruan's website. The notice instructs consignees to immediately stop using recalled devices and to destroy/dispose of devices in consignee possession. Consignees are to reply to Altruan's email with their order number and confirmation of product disposal to receive a refund.

Root Cause

No Marketing Application

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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